Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future. If you're an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
The Senior Engineer is responsible for providing technical ownership to successfully develop, qualify and transfer manufacturing technologies to commercialize new products in the Advanced Innovation Technology (AI & T) Business Unit. This individual will also advance the objectives of the Global Supply Chain (GSC) by supporting supply chain development and associated engineering activities from early product development through product launch while ensuring that manufacturing processes are developed that fully meet the operational needs for commercial success. The Senior Engineer will work collaboratively with R&D, supplier development, quality, Pilot ops etc., to support product development and deliver on the goals and objectives of the AI&T BU.
How you'll make an impact:
Apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Lead process development and validation for device releases using DMAIC methods.
Design and execute experiments to validate processes, analyze data, and report findings.
Identify and implement manufacturing improvements using Six Sigma, LEAN, and technical design approaches, ensuring equipment meets standards.
Collaborate with cross-functional teams-including Pilot Ops, GSC, R&D, PMO, Design Assurance, and Regulatory-to align objectives and fulfill BU commitments for product builds, evaluations, and assigned downstream needs.
Manage the design and development of manufacturing tools, fixtures, and equipment that meet Edwards' standards for quality, reliability, mistake-proofing, EH&S, and ergonomics.
Drive build strategy, prioritization, and technical support for QST, pre-DV, and DV phases, serving as a key partner to Pilot Ops on root-cause investigations for manufacturing processes.
Create training and documentation to support smooth process transfer to production.
Supervise manufacturing tasks, direct and train technicians, and manage their workflow.
What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education (or)
Master's Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education (or)
Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education
What else we look for (Preferred):
Proven expertise using the MS Office Suite, including MS Project; CAD experience preferred (if applicable).
Strong documentation, communication (written and verbal), and interpersonal relationship skills, including consultative and relationship-management capabilities.
Basic understanding of statistical techniques.
Previous experience working with lab or industrial equipment (if applicable).
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Strong problem-solving, organizational, analytical, and critical-thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and the ability to influence change.
Knowledge of and adherence to Edwards Environmental Health & Safety and Quality guidelines as they relate to clean-room medical device manufacturing.
Knowledge of applicable FDA regulations for the medical device industry.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Ability to work effectively in a team environment, including inter-departmental teams, and serve as a key contact representing the organization on contracts or projects.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries and environmental harm within one's span of influence/control.
Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future. If you're an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
